Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 244-971-0 | CAS number: 22413-03-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the analogue justification attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- based on water accommodated fraction
- Basis for effect:
- growth rate
- Remarks on result:
- other: Source, CAS 36078-10-1, Dako, 2013, D. subspicatus, 72 h
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- based on water accommodated fraction
- Basis for effect:
- growth rate
- Remarks on result:
- other: Source, CAS 36078-10-1, Dako, 2013, D. subspicatus, 72 h
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- based on water accommodated fraction
- Basis for effect:
- growth rate
- Remarks on result:
- other: Source, CAS 93803-87-3, 1998, S. capricornutum
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- based on water accommodated fraction
- Basis for effect:
- growth rate
- Remarks on result:
- other: Source, CAS 93803-87-3, 1998, S. capricornutum, 72 h
- Conclusions:
- The key values for the toxicity to aquatic algae are an EL50 (72 h) of > 100 mg/L and a NOELR (72 h) of ≥ 100 mg/L (nominal), based on experimental data with two structurally and chemically closely related source substances (OECD 201, D. subspicatus and S. capricornutum).
Reference
Description of key information
ErL50 (72 h) > 100 mg/L (WAF, nomminal, D. subspicatus and S. capricornutum, respectively, read-across)
NOErLR (72 h) ≥ 100 (WAF, nomminal, D. subspicatus and S. capricornutum, respectively, read-across)
Key value for chemical safety assessment
Additional information
Since no studies are available investigating the toxicity of Docosyl stearate (CAS 21443-03-2) to aquatic algae and cyanobacteria a read-across to the structurally related source substances dodecyl oleate (CAS 36078-10-1) and 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) were conducted, in accordance to Regulation (EC) No 1907/2006 Annex XI. The source substances are considered to be representative to evaluate the short-term toxicity of Docosyl stearate (CAS 21443-03-2) to aquatic algae and cyanobacteria. The target substance is an ester of stearic acid (C18) and docosanol (C22). The source substance Dodecyl oleate (CAS 36078-10-1) is an ester of similar fatty acid (C18:1) and a shorter chain alcohol (C12). 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) is described by isostearic acid (C18) and a branched alcohol (C20) with comparable chain length to the target substance). The source substances are therefore considered suitable representatives for the assessment of the short-term toxicity of the target substance to aquatic algae and cyanobacteria.
This read-across is justified in detail within the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment.
The study with the read-across substance dodecyl oleate (CAS 36078-10-1) was performed according to OECD 201 (GLP) with the green algae Desmodesmus subspicatus. Five loading rates up to 100 mg/L (nominal) were tested in this study. The loading rates were prepared by siphoning an appropriate amount from the middle after a suitable stirring and settling period (Water Accommodated Fraction). Measured values resulted in concentrations below the Limit of Quantification (< 0.005 mg/L) for all test concentrations. No effects on the growth rate and yield resulted after an exposure of 72 h. Thus, a NOErLR (72 h) of ≥ 100 mg/L and an ErL50 (72 h) > 100 mg/L resulted.
A second GLP Guideline study is available investigating the toxicity of the read-across substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) to aquatic algae. The study was performed according to OECD 201 with the freshwater algae Selenastrum capricornutum. Water Accommodated Fractions (WAF) of nominal 10 and 100 mg/L were prepared and tested under static conditions. A chemical analysis of the test substance concentrations in the test vessels was not possible since no applicable method could be established due to the very low water solubility to detect test concentrations. An inhibition of cell growth (31.2%) was observed after 72 h in the WAF test solution of 100 mg/L, whereas no inhibition was observed in the WAF test solution of 10 mg/L. It was reported that this effect is probably related to insoluble particles which might have adsorbed fractions of light needed for algal cell growth. However, the growth rate was not inhibited resulting in an EL50 (72 h) of > 100 mg/L and a NOELR (72 h) of ≥ 100 mg/L.
Based on the available result from two structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that docosyl stearate (CAS 22413-03-2) will not exhibit short-term toxicity to aquatic algae and cyanobacteria up to the limit of water solubility.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.